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Michele Cavalleri , Eurofins Biolab
Maristella Rubbiani , EU COM - DG Sante
Daniela Romano , Eurofins Biolab
Mike Baldry, Independent Consultant , UK
Darren Abrahams , Steptoe & Johnson LLP
Martina Duft , knoell Germany
Francesca Fasano , Chemsafe
Other industry experts to be confirmed soon
5TH ANNUAL BIOCIDES
CONFERENCE 2020
conference - may 6, 2020
INSIGHTS ON BPR hot topics
Biocidal product family
Data ownership
Antimicrobial efficacy
Selected speakers
the WESTIN PALACE HOTEL
MILAN - ITALY
Endocrine Disruptors
workshop - May 7, 2020
Endocrine disruptors:
From theory to practice
Session 1: Biocidal Product Family (BPF) 9:20 Risk assessment: Regulatory overviewwithin BPFTo be confirmed soon 10:00 Outcome BPF working partyIndustry expert to be confirmed soon 10:40 Consortia Formation and Cooperationfor Biocidal Product Authorisation: DifferentapproachesFrancesca Fasano, Head of Business UnitAgro/Biocides, Chemsafe 11:20 - 11:50 Coffee break 11:50 Specific Case Study on a BPFDaniela Romano, Eurofins Biolab Italy 12:20 Industry experience on a BPF: Company overviewIndustry expert to be confirmed soon 12:50 - 14:00 Lunch Break
Session 2: Endocrine Disruptors
The new EU ED Guidance – requirements,challenges and first experiences ED assessment of actives and biocidalproducts, co-formulant screeningapproach Practical implications, regulatoryconsequences and recommendations
14:30 Practical aspects related toEndocrine Disruptors assessment:
Martina DuftSenior Expert Regulatory Ecotoxicology,knoell Germany GmbH
THE OFFICIAL CONFERENCE LANGUAGEWILL BE ENGLISH
The EU COM strategy for EndocrineDisruptorsApplication of the guidelineImpact on dossier evaluationUpdate on next steps and futureperspective
14:00 Implementation of the evaluationcriteria for Endocrine Disruptors in the lightof BPR Regulation 528/2012:
Maristella Rubbiani, EU COM - DG SantePesticides and Biocides Unit
15:00 Session 3: Data OwnershipManagement
Session 4: Antimicrobial Efficacy
Disinfectant use in the veterinary sector(PT 3)Efficacy assessment and recentdevelopments of CEN methodsDeveloping an efficacy data package fora veterinary disinfectant product family
16:10 Efficacy Testing in the VeterinarySector:
Mike Baldry, Independent Consultant, UK
Laundry Disinfection (PT 2)Swimming Pool Disinfection (PT 2)Drinking Water Treatment (PT 5)
16:40 Challenging efficacy assessmentsscenarios on:
Michele Cavalleri, GLP FacilityManager - Eurofins Biolab Italy 17:10 - 17:30 Final Q&A Note: Times/topics might be subject to change We will organize in the relaxing area of theWestin Palace at the end of the Conference,on May 6th, a refreshment for speakers anddelegates. Please confirm your presencewhile submitting.
Rights and Obligations Refresher Lessons from the BoA and ECHA Novel data scenarios
Darren AbrahamsPartner, Steptoe & Johnson LL 15:40 - 16:10 Coffee break
MAY 06, 2020 - CONFERENCE - FULL DAY
AGENDA
9:10 Welcome and introduction Moderator, Daniela Romano, RegulatoryAffair Manager for Biocidal Products,Eurofins Biolab
ANNUAL BIOCIDES CONFERENCE 2020
9:30 Endocrine Disruptors - definition andcriteria* 10:00 Main requirements of new EU EDGuidance* 10:30 Gathering and assembly of data* 11:00 Coffee break 11:15 Assembly of the lines of evidence,evaluation of completeness* 11:45 Regulatory consequences for applicantsand implications on dossier preparation**Martina DuftSenior Expert Regulatory Ecotoxicology, knoell Germany GmbH 12:15 Specific Case Study****Daniela Romano, Regulatory Affair Managerfor Biocidal Products, Eurofins Biolab 12:45 - 13:00 Final Q&A ì.
MAY 07, 2020 - HALF DAY
P O S T C O N F E R E N C E W O R K S H O P
ENDOCRINE DISRUPTORS: FROM THEORY TO PRACTICE
Delegates can select a joint registration toattend both the Conference and theWorkshop with a discount rate. For more details on speakers and furtherassistance please contact us at:[email protected] Full Conference and Workshop details:https://www.eurofins.it/formazione/conferenze-e-workshop/
Agenda (9.30h - 13.00h)
THE OFFICIAL WORKSHOP LANGUAGEWILL BE ENGLISH
ANNUAL BIOCIDESCONFERENCE 2020
ED properties of Biocidal Products havebecome a hot topic since 07 June 2018,because evaluating competent authoritiesassess the potential ED properties of allbiocidal products. The ECHA/EFSA guidance for theidentification of endocrine disruptors, impliesrising standards and challenging requirementsfor the assessment of all substances. Thecompetent authorities will also take intoconsideration the ED properties of substancesand products for procedures that are stillunder evaluation. This higly complex andrigorous approach impacts all aspectsassociated to data requirements, testing andassessment strategies. Applicants should:• Review the active substances in the light of the scientific ED criteria and the new EU ED Guidance• Be prepared to provide more information on the possible ED properties of active substances in their application• Consult the national authority responsible for the evaluation of active substances before testing These criteria will apply not only to activesubstances but also to co-formulants, whichare especially critical within ED assessmentframework. This workshop aims to provide a fullunderstanding and in-depth insight into thenew EU Endocrine Disruptor criteria, and therecent ECHA/EFSA ED Guidance. Key industryexperts will share valid and sound knowledgefor identifying endocrine disrupting chemicalsin the biocides area.
Introduction
Daniela Romano, Regulatory Affair Manager forBiocidal Products, Eurofins Biolab ItalyAfter her PhD in Biophysics and a Post Docposition in medical research, Daniela has beenworking with Eurofins, mainly on Biocides,since 2003. She was first in charge of stabilitystudies and then the management of theChemistry laboratory. She managed projectsaiming towards Biocidal Products authorisationfor several years and is now also involved inthe risk assessment procedures. She has soundexperience with a large variety of biocidalproducts. Maristella RubbianiNational Seconded Expert at EU COM - DGSante Pesticides and Biocides UnitMaristella is a member of the CA, BPCCommittee and the national Committee forauthorization of biocides and PPPs. She isresponsible of the national database for poisoncentres according to Art 45 CLP and has morethan 30 years of experience in regulatorytoxicology and C&L for risk assessment ofsubstances and preparations.She has a degree in Biology and a PhD inIndustrial and Environmental Hygiene. Martina DuftSenior Expert Regulatory Ecotoxicologyknoell Germany GmbHDr Martina Duft is senior expert regulatoryecotoxicologist at knoell Germany GmbH. Shestudied biology at the Ludwig MaximilianUniversity Munich and is holding a PhDin ecotoxicology from the JW Goethe UniversityFrankfurt. After several years in ED relatedresearch, she has worked for >15 years invarious regulatory sectors with a focuson ecotoxicology and regulatory affairs. She iscoordinator of the knoell ED expert team andkey contact for the topic endocrine disruptors. Michele Cavalleri, GLP Facility ManagerEurofins Biolab ItalyHe has gained a solid expertise on efficayassessment of disinfectants. He is alsomember of the European Committee CEN TC216 that establishes standardized methods oftest and requirements for the antimicrobialefficacy of chemical disinfectants andantiseptics.
Mike BaldryIndependent Consultant, UKMike has worked for over 40 years ondisinfectant development and regulation invarious companies and has been involvedwith European biocides regulation since theearliest days of the BPD. He now works part-time as an independent regulatoryconsultant and continues his activeinvolvement in biocides regulation andefficacy. He is Convenor of the CEN TC/216Working Group 2, responsible for standardsfor assessing the efficacy of disinfectantsused in the veterinary sector. Francesca FasanoHead of Business Unit Agro/Biocides,ChemsafeFrancesca has a sound expertise inchemistry with a Degree in IndustrialChemistry, one in Chemistry, and a PhD inAnalytical Chemistry. During the PhD sheworked at the US EPA in Athens (GA).Between 2008 and 2010 Francescaparticipated in several research projects inanalytical chemistry, with scholarships atthe University of Turin, and at the IstitutoZooprofilattico of Turin. Since January 2011she works at Chemsafe on Agro/biocideprojects. In 2015 Francesca became Head ofthe Agro/biocide BU. In 2020 Francescabecame head of the Chemical BU. Darren AbrahamsPartner, Steptoe & Johnson LLP, BelgiumDarren enables clients throughout thechemicals and life sciences supply chain toget and keep their products on the EuropeanUnion market. He focuses on defense ofproducts through strategic advice, advocacybefore institutions and agencies, andlitigation before EU and national courts andtribunals. He has a wealth of experiencewith the EU regulation of biocidal products,plant protection products (agrochemicals),REACH, classification, labelling andpackaging, GM food and feed, cosmetics,and endocrine disruptors. Other industry experts to be confirmed soon.
TOP SPEAKERS
ANNUAL BIOCIDESCONFERENCE 2020
Title, First name, Second name:___________________________________________________Company:___________________________________________________Department:___________________________________________________Company address:___________________________________________________Bill-to-address (if different):___________________________________________________Phone/Mobile number:___________________________________________________E-mail: ___________________________________________________ Important: Indicate your company's VAT ID number: ___________________________________________________ I will attend post-Conference refreshment on May 6th,2020: YES NO Date: Signature:_______________ ________________________________ Email this form to: [email protected]
EARLY BIRD PRICE VALID UNTIL MARCH 31ST, 2020
FULL PRICE VALID AFTER MARCH 31ST, 2020
VENUE AND TIMING
BANK DETAILS
REGISTRATION FORM
ORGANIZATION AND CONTACTS
Conference and Workshop:330€ + VAT (if applicable) Conference attendance only (May 6th, 2020):*260€ + VAT (if applicable) Workshop attendance only (May 7th, 2020):**120€ + VAT (if applicable)
The Westin Palace, MilanPiazza della Repubblica, 20, 20124 Milan https://www.marriott.com/hotels/travel/milwi-the-westin-palace-milan/ Conference: May 6th, 202009:10h - 17:30hRegistration of delegates: 08:45h-09:10h Post Conference refreshment: 17:45h Workshop: May 7th, 202009:30h - 13:00hRegistration of delegates: 09:00h-09:30h
UNICREDIT SPAABI: 2008 CAB: 20600 CIN: NC/C: 000004846325IBAN: IT04 N020 0820 6000 0000 4846 325VAT ID: 00762140960
Conference and Workshop:420€ + VAT (if applicable) - First delegate380€ + VAT (if applicable) - Second delegate Conference attendance only (May 6th, 2020):*350€ + VAT (if applicable) - First delegate*310€ + VAT (if applicable) - Second delegate Workshop attendance only (May 7th, 2020):**150€ + VAT (if applicable) - First delegate**130€ + VAT (if applicable) - Second delegate *Conference day lunch included **Workshop day lunch not included PAYMENT OPTION VALID: BANK TRANSFER
Eurofins BioPharma Product Testing ItalyVia Bruno Buozzi, 220090 - Vimodrone (MI)Tel. + 39 0225071535e-mail: [email protected]://www.eurofins.it/formazione/conferenze-e-workshop/
Terms and ConditionsThe organizer will confirm your participation afterreceiving the signed registration form.The organizer requires the full payment of theregistration fee in advance through bank transfer.Only after we have received your payment, you areentitled to attend the Conference and/or Workshop.If you cannot attend the Conference or Workshopyou have two options:1. We are happy to welcome a substitute colleagueat any time.2. If you have to cancel entirely we must charge thefollowing processing fees:- until 1 week prior to the event 50% of theregistration fee will be charged;- less than 1 week prior to the conference fullregistration fee will be charged.Registration fee includes participation,refreshments, lunch (if available) anddocumentation package.Eurofins BioPharma Product Testing Italy reservesthe right to cancel/alter the programme, thespeakers, the date or venue. If the event must becancelled, registrants will be notified as soon aspossible and will receive a full refund of fees paid.Eurofins BioPharma Product Testing Italy is notresponsible for airfare, hotel or other costs incurredby registered delegates. Your data will be processed in accordance with EUregulation no. 679 of 27 April 2016 and LegislativeDecree 30 June 2003, n. 196.By sending this form, you confirm that you haveread and accepted the Terms and Conditions.